A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction

June 21, 2017 updated by: Janssen Korea, Ltd., Korea

Post-Marketing Surveillance of Bravonto in Korea

The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Study Type

Observational

Enrollment (Actual)

379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.

Description

Inclusion Criteria:

  • Participants diagnosed with erectile dysfunction
  • Participants prescribed mirodenafil on demand

Exclusion Criteria:

- Participants who have administered mirodenafil for other than an approved indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mirodenafil
Drug: No intervention
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Up to 4 weeks
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to 12 weeks
Up to 12 weeks
International Index of Erectile Function
Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12
The International Index of Erectile Function is used for the assessment of erectile dysfunction, with scores ranging from 0 to 30. Evaluation of points are as follows: 1-10 = severe erectile dysfunction, 11-16 = moderate dysfunction, 17-21 = mild to moderate dysfunction, 22-25 = mild dysfunction, 26-30 = no dysfunction. Lower scores indicate worsening.
Baseline (Week 0), Week 4, Week 8, and Week 12
Sexual Encounter Profile
Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12
The Sexual Encounter Profile is assessed after each sexual attempt consisting of a series of yes/no questions regarding specific aspects of each encounter. Question 1 asks, "Were you able to insert your penis into your partner's vagina?" and question 2 asks, "Did your erection last long enough for you to complete intercourse with ejaculation?".
Baseline (Week 0), Week 4, Week 8, and Week 12
Global assessment Questionnaire
Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12
The Global Assessment Questionnaire is a self-administered questionnaire (Yes/No) that allows men to rate improvement in erectile function. Question 1 asks "Has the treatment you have been taking over the past 4 weeks improved your erections?" and if the answer is yes, question 2 then asks "Has the treatment improved your ability to engage in sexual activity"
Baseline (Week 0), Week 4, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2011

Primary Completion (Actual)

May 31, 2012

Study Completion (Actual)

May 31, 2012

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100836
  • MIRODENEDY4002 (Other Identifier: Janssen Korea, Ltd., Korea)
  • MIR-KOR-PMS (Other Identifier: Janssen Korea, Ltd., Korea)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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